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Safety, acceptability, and potential efficacy of a topical penile microbicide wipe
Taha E Taha1, Newton Kumwenda, Albert Mwakomba
1Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205, USA. ttaha@jhsph.edu
Abstract:
Innovative, low-cost, and acceptable measures are needed to reduce sexually transmitted infections (STIs) including HIV. Use of a topical microbicide wipe for penile cleaning before and after sex might be effective in preventing STIs. However, evaluation of this simple method has not been done. Two studies were conducted in Malawi to determine the safety, acceptability, and potential efficacy of a benzalkonium chloride topical penile microbicide wipe. The first study was a phase 1 dose-escalating clinical trial among low-risk circumcised or uncircumcised HIV-negative men. The second study was a pilot before-after efficacy study among uncircumcised HIV-negative or -positive men. In the first study 24 circumcised and 27 uncircumcised men were enrolled. During the entire study period, 18 adverse events (AEs) were reported, and 3 AEs were confirmed by physical examination. Acceptability concerns did not increase with dose escalation, and adherence to use of the wipe ranged from 89%-95%. In the second study, 27 men were enrolled. Gram stain and culture tests showed significant reductions in frequency of several organisms after use of the wipe, including STI-associated bacteria. This penile wipe is safe, acceptable, and can decrease the frequency of penile colonization with microorganisms. The clinical relevance remains to be determined in larger clinical trials.
Insights
A new penile wipe using benzalkonium chloride is safe and acceptable for men. This topical microbicide wipe shows potential for reducing sexually transmitted infections (STIs) by decreasing penile bacteria.
Area of Science:
- Infectious Diseases
- Public Health
- Microbiology
Background:
- Innovative strategies are crucial for reducing the burden of sexually transmitted infections (STIs), including HIV.
- Topical microbicides, such as penile wipes, offer a potential low-cost method for STI prevention.
- Previous evaluations of penile microbicide wipes for STI prevention are limited.
Purpose of the Study:
- To assess the safety and acceptability of a benzalkonium chloride penile microbicide wipe in men.
- To evaluate the potential efficacy of the penile wipe in reducing penile microorganisms, including STI-associated bacteria.
Main Methods:
- Phase 1 dose-escalating clinical trial in HIV-negative circumcised and uncircumcised men.
- Pilot before-after efficacy study in uncircumcised men (HIV-negative or -positive).
- Adverse events monitoring, acceptability assessment, adherence tracking, and microbiological testing (Gram stain, culture).
Main Results:
- The penile wipe was found to be safe, with a low incidence of confirmed adverse events.
- High adherence rates (89%-95%) and acceptable user experience were reported, without increased concerns with dose escalation.
- Significant reductions in the frequency of various microorganisms, including STI-associated bacteria, were observed after wipe use.
Conclusions:
- Benzalkonium chloride penile microbicide wipes are safe and acceptable for men.
- The penile wipe demonstrates potential in reducing penile colonization by microorganisms.
- Further large-scale clinical trials are necessary to determine the clinical relevance for STI prevention.
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